Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01640366
Description: None
Frequency Threshold: 5
Time Frame: Baseline through 90 days postoperatively.
Study: NCT01640366
Study Brief: PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care Dressing Arm Adhesive Skin Closure Strips, e.g. STERI-Strips, or alternatively a non-adherent dry dressing if Adhesive Skin Closure Strips was not deemed appropriate by the Principle Investigator at that center. 0 None 7 200 70 200 View
PICO Negative Pressure Wound Therapy PICO: Single-use Negative Pressure Wound Therapy system (su-NPWT) 0 None 2 200 50 200 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Epidermolysis at T-junction/skin trifurcation point SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Fat necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Hematoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Infection and dehiscence SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Severe postoperative pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Delayed wound healing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View